Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]
Completed · Phase 4
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment The secondary objectives of this study include: 1. To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy. 2. To compare the time to first severe COPD exacerbation in both treatment arms. 3. To compare the annual rate of severe COPD exacerbations in both treatment arms. 4. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.
Key facts
- Study ID
- NCT03265145
- Run by
- Boehringer Ingelheim
- People needed
- 714
- Starts
- 2017-09-20
- Expected to finish
- 2020-09-30
- Last updated by the study team
- 2022-06-14
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- COPD diagnosis as defined by the study physician
- Currently on one of the following maintenance therapies:
- LAMA monotherapy
- LABA monotherapy
- ICS/LABA (FDC)
- Physician determination that patient is not controlled on current pharmacotherapy
- Adult patient 40 years of age or older at time of study enrollment
- Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.
You may not qualify if…
- Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)
- Contraindication to any study medications (LAMA, LABA or ICS)
- Documented diagnosis of current asthma
- Pregnant or nursing women
- Women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
Where it is running
- Healthscan Clinical Trials LLC — Montgomery, Alabama, United States
- HealthScan Research — Montgomery, Alabama, United States
- Diamond Childrens Medical Center — Tucson, Arizona, United States
- CareMore Apple Valley Care Center — Apple Valley, California, United States
- HealthCare Partners — Commerce, California, United States
- Advanced Research Center, Inc. — Murrieta, California, United States
- Newport Native MD, Inc — Newport Beach, California, United States
- Aureus Medical Group, Inc — Rancho Cucamonga, California, United States
- Capital Allergy and Respiratory Disease Center — Roseville, California, United States
- Paloma Medical Group — San Juan Capistrano, California, United States
- Adnab Research/Prestige Care Physician — Torrance, California, United States
- Pulmonary and Sleep of Tampa Bay — Brandon, Florida, United States
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
- Saint Francis Sleep, Allergy and Lung Institute, LLC — Clearwater, Florida, United States
- Cohen Medical Research Associates, LLC — Delray Beach, Florida, United States
- Gary J. Richmond, M.D., PA — Fort Lauderdale, Florida, United States
- Medical Research of Central Florida — Leesburg, Florida, United States
- Florida Lung and Sleep Associates — Lehigh Acres, Florida, United States
- TRY Research — Maitland, Florida, United States
- Pro Live Medical Research — Miami, Florida, United States
- Advanced Research for Health Improvement, LLC — Naples, Florida, United States
- Oviedo Medical Research — Oviedo, Florida, United States
- Bassetti Medical Research Inc — Sebring, Florida, United States
- Pasadena Ctr for Medical Rsrch — St. Petersburg, Florida, United States
- Pulmonary Associates of Mobile, PC — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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